Orexo neurology news
Orexo retained Guggenheim Securities as its financial advisor to evaluate a "full range of strategic alternatives" for its U.S. commercialization plan. Orexo expects to launch Zubsolv buprenorphine/naloxone in the U.S. in 3Q13 to treat opioid dependence. In September, Orexo submitted an NDA to FDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. In June, Orexo said it will reacquire U.S. rights to the breakthrough cancer pain drug Abstral fentanyl, effective Jan. 1, 2013, from the ProStrakan Group plc subsidiary of Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151, Tokyo, Japan). Zubsolv is a sublingual tablet formulation of buprenorphine and naloxone. At June 30, Orexo had SEK426.1 million ($61.1 million) in cash and a six-month operating expense of SEK72 million ($10.3 million) (see BioCentury, June 11). ...